Applicator for Applying a Fluid to a Surface

ABSTRACT

An applicator for applying a fluid to a surface is provided, the applicator comprising a support comprising an upper outer surface and a lower holding surface; a flexible membrane comprising a central opening, an inner wall comprising a lower end and an upper end, an outer wall at least partially surrounding the upper outer surface of the support, the outer wall comprising a lower end and an upper end, and an upper folded wall connecting the upper ends of the inner wall and outer wall; and a membrane holder for fixedly securing the lower end of the inner wall of the flexible membrane to the upper outer surface of the support; wherein the upper surface of the membrane holder and the inner wall of the flexible membrane define a reservoir for holding a fluid, and wherein the lower end of the outer wall of the flexible membrane is free to move axially relative to the upper outer surface of the support when pressure is applied to the upper folded wall of the flexible membrane. In an embodiment, the applicator has particular utility for applying a topical or transdermal testosterone composition to the skin of a patient in need of testosterone replacement therapy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of priorityof pending U.S. application Ser. No. 14/100,817, filed on Dec. 9, 2013.The foregoing application and all documents cited therein are herebyincorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

The present invention relates to an applicator for applying a fluid to asurface. In embodiments, the applicator is useful for applying amedicament-containing fluid to the skin. In particular embodiments, theapplicator is useful for applying a topical or transdermal testosteronecomposition to the skin of a patient in need of testosterone replacementtherapy.

It is known from U.S. Pat. No. 8,177,449 to Bayly et al. to provide animplement for applying a volume of liquid containing testosterone to anunderarm or axilla skin surface. This implement includes a cylindricalrigid support or handle on which a resiliently deformable thin flexiblemembrane is mounted. The membrane has a generally circular shape, withan inner circular area or base in contact with, but not secured to, theupper surface of the cylindrical rigid support. The membrane extendsupwardly away from the circumference of the fixed inner circular areaand is folded over to create an upper folded edge. The membrane thenextends back down towards the rigid support, with the outercircumference of the membrane forming a lower outer edge which is fixedin position to the rigid support. With this structure, the secured innercircular area or base, and the upstanding wall, form a reservoir. Inoperation, a volume of liquid is pumped into the reservoir. The upperfolded edge the membrane is then rubbed over the skin surface to whichthe liquid is to be applied, whereby the upper folded edge spreads theliquid over this skin surface.

However, it has been found that, with the implementation of this patent,the upper folded edge of the membrane tends to deform rather than rollover the skin surface. As a result of this deformation, a seal isdifficult to maintain, with some leakage of the liquid from between theimplement and the skin surface. In addition, because of this action,underarm hairs tend to be pulled, causing discomfort to the person.

SUMMARY OF THE INVENTION

In aspects, the present invention provides an applicator that overcomesthe aforementioned problems.

In one aspect, the present invention provides an applicator for applyinga fluid to a surface, the applicator comprising:

1) a support comprising an upper outer surface and a lower holdingsurface;

2) a flexible membrane comprising:

-   -   a central opening,    -   an inner wall comprising a lower end and an upper end,    -   an outer wall at least partially surrounding the upper outer        surface of the support, the outer wall comprising a lower end        and an upper end, and    -   an upper folded wall connecting the upper ends of the inner wall        and outer wall; and

3) a membrane holder for fixedly securing the lower end of the innerwall of the flexible membrane to the upper outer surface of the support;wherein the upper surface of the membrane holder and the inner wall ofthe flexible membrane define a reservoir for holding a fluid, andwherein the lower end of the outer wall of the flexible membrane is freeto move axially relative to the upper outer surface of the support whenpressure is applied to the upper folded wall of the flexible membrane.

In another aspect, the present invention provides a kit comprising thedisclosed applicator, a dispenser bottle containing a fluid, and a capadapted to engage the support and cover the flexible membrane.

In another aspect, the present invention provides a method of applyingtopical or transdermal testosterone composition to the skin of a humanin need thereof, the method comprising providing the disclosedapplicator, placing the topical or transdermal testosterone compositionin the reservoir of the applicator, and applying the topical ortransdermal testosterone composition from the reservoir to the skin.

Various embodiments of aspects of the invention are disclosed below. Theabove and other features of the invention will become readily apparentfrom the following detailed description thereof which is to be read inconnection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an applicator according to the presentinvention, mounted on a dispenser bottle;

FIG. 2 is a perspective view of the applicator according to the presentinvention, mounted on a dispenser bottle, with the cap removed;

FIG. 3 is a perspective view of a dispenser bottle on which theapplicator according to the present invention is adapted to be mounted;

FIG. 4 is an exploded, front elevational view of the applicator anddispenser bottle;

FIG. 5 is a cross-sectional view of the applicator of FIG. 4, takenalong line 5-5 thereof;

FIG. 6 is an exploded, side elevational view of the applicator anddispenser bottle;

FIG. 7 is a cross-sectional view of the applicator of FIG. 6, takenalong line 7-7 thereof;

FIG. 8 is an enlarged cross-sectional view of the applicator of FIG. 5in assembled form;

FIG. 9 is an enlarged cross-sectional view of the applicator of FIG. 7in assembled form;

FIG. 10 is a top perspective view of the rigid support of theapplicator;

FIG. 11 is a bottom perspective view of the rigid support;

FIG. 12 is a front elevational view of the rigid support;

FIG. 13 is a side elevational view of the rigid support;

FIG. 14 is a top plan view of the rigid support;

FIG. 15 is a bottom plan view of the rigid support;

FIG. 16 is a top perspective view of the diaphragm of the applicator;

FIG. 17 is a bottom perspective view of the diaphragm;

FIG. 18 is a front elevational view of the diaphragm;

FIG. 19 is a side elevational view of the diaphragm;

FIG. 20 is a top plan view of the diaphragm;

FIG. 21 is a bottom plan view of the diaphragm;

FIG. 22 is a longitudinal cross-sectional view of the diaphragm;

FIG. 23 is a top perspective view of the diaphragm holder of theapplicator;

FIG. 24 is a bottom perspective view of the diaphragm holder;

FIG. 25 is a front elevational view of the diaphragm holder;

FIG. 26 is a side elevational view of the diaphragm holder;

FIG. 27 is a top plan view of the diaphragm holder;

FIG. 28 is a bottom plan view of the diaphragm holder;

FIG. 29 is a top perspective view of the skirt of the applicator;

FIG. 30 is a front elevational view of the skirt;

FIG. 31 is a side elevational view of the skirt;

FIG. 32 is a top plan view of the skirt;

FIG. 33 is a bottom plan view of the skirt;

FIG. 34 is a top plan view of the cap;

FIG. 35 is a bottom plan view of the cap;

FIG. 36 is an exploded, front elevational view of the modifiedapplicator and dispenser bottle;

FIG. 37 is a cross-sectional view of the applicator of FIG. 36, takenalong line 37-37 thereof;

FIG. 38 is an exploded, side elevational view of the modified applicatorand dispenser bottle;

FIG. 39 is a cross-sectional view of the applicator of FIG. 38, takenalong line 39-39 thereof;

FIG. 40 is an enlarged cross-sectional view of the applicator of FIG. 37in assembled form;

FIG. 41 is an enlarged cross-sectional view of the applicator of FIG. 39in assembled form;

FIG. 42 is a top perspective view of the rigid support of the applicatorof FIG. 36;

FIG. 43 is a bottom perspective view of the rigid support of FIG. 42;

FIG. 44 is a front elevational view of the rigid support of FIG. 42;

FIG. 45 is a side elevational view of the rigid support of FIG. 42;

FIG. 46 is a top plan view of the rigid support of FIG. 42;

FIG. 47 is a bottom plan view of the rigid support of FIG. 42;

FIG. 48 is a top perspective view of the diaphragm of the applicator ofFIG. 36;

FIG. 49 is a bottom perspective view of the diaphragm of FIG. 48;

FIG. 50 is a top plan view of the diaphragm of FIG. 48;

FIG. 51 is a bottom plan view of the diaphragm of FIG. 48, together witha diaphragm holder;

FIG. 52 is a top perspective view of the skirt of the applicator of FIG.36;

FIG. 53 is a bottom perspective view of the skirt of FIG. 52; and

FIG. 54 is a front elevational view of the skirt of FIG. 52.

DETAILED DESCRIPTION

Referring to the drawings in detail, there is shown in FIG. 1 anembodiment of applicator 10 for applying a fluid to a surface accordingto the present invention.

Reference to a “surface” is used herein to include any solid orsemi-solid material having one or more areas capable of being contactedwith an applicator, such as woods, metals, minerals, ceramics, glasses,plastics, polymers, composite materials, and the like, as well as animalsurfaces, such as skin and other organ surfaces. Reference to a “fluid”used herein is intended to include any flowable substance, such asliquids, solutions, foams, lotions, gels, creams, pastes, and the like.Embodiments of the applicator described herein have particular utilityin the application of a medicated topical or transdermal fluidcontaining testosterone to the axilla of a human. In this way, contactof the medicated fluid with the user's hand can be avoided, therebyminimizing unintended interpersonal transfer of testosterone.

Applicator 10 is intended to seat upon the upper end of a bottle 12containing the fluid, the bottle 12 having a pump dispenser 14 fordispensing the fluid to applicator 10 when applicator 10 is removed frombottle 12. As shown best in FIG. 3, bottle 12 has a main body 16 with agenerally oval cross-sectional shape, and the upper open end of which isclosed by pump dispenser 14. Pump dispenser 14 has a lower annular wall18 of a first diameter that seats on the upper end of main body 16. Thelower edge of an intermediate annular wall 20 of a second, smallerdiameter is connected to the upper edge of lower annular wall 18 by anannular shoulder 22. The lower edge of an upper annular wall 24 of athird, still smaller diameter is connected to the upper edge ofintermediate annular wall 20 by an annular shoulder 26. A pump 28 of thepump dispenser 14 is fit within upper annular wall 24 and operates in awell-known manner which is not described herein.

As shown in FIGS. 2 and 5-15, applicator 10 includes a thin walled,rigid support 30, preferably of a rigid plastic material, having agenerally oval configuration, although the present invention is notlimited to this configuration. Rigid support 30 functions as a handle orholder. Rigid support 30 is formed as a unitary, single piece structure,and is formed of three thin-walled sections 32, 34 and 36 connected toeach other in succession. Lower section 32 has a generally oval shapesimilar to that of main body 16 and forms a holder by which a person canhold applicator 10 during use of applicator 10. Intermediate section 34also has a generally oval shape but with slightly less dimensions thanlower section 32, with the lower edge of intermediate section 34connected to the upper edge of lower section 32 by an oval shoulder 38.Upper section 36 also has a generally oval shape but with smallerdimensions than intermediate section 34, with the lower edge of uppersection 36 connected to the upper edge of intermediate section 34 by anoval shoulder 40.

Two sets of substantially parallel, spaced-apart ribs 42, 44, 46, 48 and50 extend continuously along the inner surface of intermediate section34 from the upper end thereof to a position about one-third of the waydown the inner surface of lower section 32, with each set being inopposing relation to the other set and the ribs extending in thedirection of the center axis of lower section 32. The inner edges ofeach rib 42, 44, 46, 48 and 50 extend around a circular area, and eachrib faces inwardly along a radius of the circular area. Thus, becausethe inner surface of lower section 32 has an oval section, outer ribs 42and 50 extend inwardly to a greater extent than middle ribs 44 and 48,and middle ribs 44 and 48 extend inwardly to a greater extent than thecenter rib 46. In this manner, when lower section 32 seats on main body16 of bottle 12, the lower edges of ribs 42, 44, 46, 48 and 50 seat onannular shoulder 22, and the inner edges of ribs 42, 44, 46, 48 and 50frictionally engage the outer surface of intermediate annular wall 20.In addition, further ribs 52 extend axially down from the lower ends ofribs 42 and to the lower edge of lower section 32, with ribs 52 havingvery small inward dimensions so as to effectively form small beads. Whenrigid support 30 is positioned on main body 16 such that ribs 42, 44,46, 48 and 50 frictionally engage the outer surface of intermediateannular wall 20, ribs 52 function to provide some frictional engagementwith the outer wall of main body 16 to prevent wobbling of rigid support30 on main body 16.

The number of ribs can vary, as desired, for devices of differentdimensions and materials of construction.

The outer surface of intermediate section 34 is provided with fourequiangularly spaced elongated depressions 35 around a common peripheralline, immediately above shoulder 38, the purpose for which will beunderstood from the description hereafter.

The upper edge of upper section 36 is closed off by an upper oval shapedtop wall 54, and reinforcing ribs 56 connect opposing inner surfaces ofupper section 36 and are connected to the inner or lower surface of topwall 54. Vent openings 58 can be provided in top wall 54 between ribs56. In addition, two guide openings 60 are provided in oval top wall 54at opposite ends of the longer axis thereof, and a central securingopening 62 is provided along the same longer axis between guide openings60. Vent openings 58 are provided to opposite sides of this longer axis.Lastly, an upper oval lip 63 extends upwardly, slightly inward from theouter periphery of top wall 54.

As shown best in FIGS. 2, 5-9 and 16-22, a thin-walled flexible membraneor diaphragm 64, in certain embodiments formed from a silicone rubbermaterial (in particular medical grade silicone rubber where a medicatedfluid is to be applied to skin), but not limited thereto, has a centralopening 66 of an oval shape, with the inner periphery being thickened toform an oval shaped ring 68 of the same material, which also extendsbelow central opening 66 to form an oval lip 67 and which has in-turnednubs 70 extending inwardly toward each other along the large axis of theoval shape.

From the outer periphery of oval shaped ring 68, membrane 64 continuesupwardly along an inner wall section 72, is folded over at its upper endto form an upper folded end 74 and then continues downwardly to form anouter wall section 76. Upper folded end 74 in this embodiment forms acontinuous oval shape. However, unlike the lower end of the outer wallsection of the implement of U.S. Pat. No. 8,177,449 to Bayly et al.,which is fixed to the implement, the lower end 78 of outer wall section76 according to the present invention is not fixed to support 30, and infact, is free to move axially relative to upper section 36 duringapplication of a fluid to the surface. As a result, when the userapplies membrane 64 to the surface, and pressure is applied to the upperfolded end 74, lower end 78 moves distally down upper section 36 towardsmiddle section 34, resulting in little to no lateral deformation ofupper folded end 74 against the surface. Rather, upper folded end 74deforms relatively uniformly around its perimeter along an axis that istransverse to central opening 66, resulting in more of a rolling action,which allows for a tighter seal with the surface. In certainembodiments, a vacuum seal is created. As a result, relatively lessleakage of fluid may occur when membrane 64 is moved laterally acrossthe surface. When applied to a skin surface, pulling of hair may bereduced during lateral movement of membrane 64.

As will be appreciated from the discussion hereafter, lower end 78 isthickened with the same material, to form an oval shaped lip 77extending inwardly from lower end 78, with lip 77 having a generallysquare or rectangular cross-section, and with opposite nubs 79 extendingupwardly in an axial direction at an upper surface of lip 77 at theinner periphery thereof, along the long axis of the oval shape of lip77.

Oval shaped ring 68 is fixed to the upper surface of oval shaped topwall 54 by a membrane holder 80, which is best shown in FIGS. 2, 5-9 and23-28. Membrane or diaphragm holder 80 includes a generally oval plate82 having a slightly convex upper surface, a downturned lip 84 at theouter periphery thereof, and an oval downturned wall 86 of greaterheight than lip 84 and spaced inwardly from downturned lip 84 to form anoval recess 88 therebetween. A long rib 90 extends between oppositesides of oval downturned wall 86 along the long axis thereof and a shortrib 92 extends between opposite sides of oval downturned wall 86 alongthe short axis thereof, with both ribs also connected to the lowersurface of plate 82. A central boss 94 extends downwardly from the lowersurface of plate 82 at the intersection of ribs 90 and 92 and has aninternal opening 95, preferably threaded. Two guide pins 96 extend downfrom opposite ends of long rib 90. In addition, oval downturned wall 86includes cut-outs 98 at positions corresponding to the ends of long rib90, to the outside of guide pins 96.

With this structure, after membrane 64 is positioned on rigid support 30by positioning oval lip 67 on top wall 54 and within the confines ofupper oval lip 63 thereof, membrane holder 80 is positioned on top ofring 68 such that downturned lip 84 at the outer periphery thereof sitson ring 68, and downturned wall 86 fits within the confines of ring 68.At the same time, nubs 70 of membrane fit within cut-outs 98. In thisregard, nubs 70 and cut-outs 98 form first and second alignmentelements, respectively.

At the same time, guide pins 96 fit through guide openings 60, andcentral boss 94 fits through central securing opening 62. Thereafter, asecurement member 100 is threadedly screwed from below into internalopening 95 of central boss 94 to fixedly secure ring 68 to top wall 54in a fluid sealing manner.

A reservoir 103 for holding a fluid is thereby defined by the uppersurface of plate 82 of membrane holder (which now covers and closescentral opening 66 of membrane 64) and the inner wall section 72 ofmembrane 64 extending upwardly therefrom. Where a medicated fluid is tobe applied to skin, plate 82 is preferably made of a material that iscompatible with the medicated fluid (e.g., does not leach) and is safefor contact with skin.

At this time, outer wall section 76 of membrane is positioned insurrounding relation to upper section 36 with the lower end 78 thereofbeing free and movable in the axial direction of upper section 36.

In order to better provide for controlled free sliding movement of lowerend 78 of outer wall section 76, in a preferred embodiment best shown inFIGS. 29-33, lower end 78 is fixed over an oval skirt 102 which haslarger dimensions than the outer dimensions of upper section 36 so thatit too can move axially relative to upper section 36.

Skirt 102 is formed by an upper oval plate 104 and a lower oval plate106 connected together in parallel, spaced apart relation by a pluralityof equiangularly spaced connecting walls 108 connected at inner edges ofplates 104 and 106. Thus, an oval recess 110 is defined by plates 104and 106, and connecting walls 108. In addition, upper wall includes twosmall openings 112 at the outer edge thereof in opposing relation toeach other along the long axis of the oval shape of skirt 102.Accordingly, oval shaped lip 77 of membrane 64 fits within oval recess110 and is retained therein. At the same time, nubs 79 of membrane 64fit within small openings 112.

Lastly, when not in use, a cap 114 is provided for covering membrane 64.Specifically, as best shown in FIGS. 34-35, cap 114 includes athin-walled oval section 116 which is open at its lower end and which isclosed by an oval top wall 118 at its upper end. Thin-walled ovalsection 116 includes four equiangularly spaced elongated beads 120 atthe inner surface thereof immediately adjacent the lower open end, forengaging in the four equiangularly spaced elongated depressions 35 ofintermediate section 34, so as to releasably lock cap 112 ontointermediate section 34 when applicator 10 is not in use. At such time,the lower edge of thin-walled oval section 116 rests on oval shoulder38.

A kit can be provided comprising applicator 10, bottle 12 and cap 114.In operation, when used to apply a fluid to a skin surface, applicator10 is removed from bottle 12 and cap 114 is removed from intermediatesection 34. Thereafter, a dose of fluid from bottle 12 is pumped intoreservoir 103 by pump 28. Holding support 30, upper folded end 74 ofmembrane 64 is then placed in contact with the skin surface, causinglower end 78 to move distally down upper section 36 of support 30towards middle section 34, thereby creating a seal (preferably a vacuum)between membrane 64 and the skin surface. Upper folded end 74 may thenbe moved across the skin surface by the user until the desired amount offluid has been applied from the reservoir to the skin.

If the fluid contains a medicament, reservoir 103 can be washed afteruse to reduce the likelihood of interpersonal transfer of themedicament. The medicated fluid can contain any physiologically activeagent which can be delivered to the skin to achieve a desired effect.Thus, the applicator may be used to apply drugs, vitamins, cosmetics,sunscreens, and the like. The medicated fluid may also contain one ormore inactive agents, including any one or more of carriers, thickeningagents, volatile agents, penetration enhancers, pH adjusting agents,preservatives, surfactants, occlusive agents, emulsifiers, colorants,and the like.

In a particular embodiment, applicator 10 is used to apply a topical ortransdermal testosterone composition to the skin of a human in needthereof. Any composition capable of delivering testosterone through theskin can be used and are well known in the art. Any condition can betreated wherein an increase in blood testosterone levels is desired. Inan embodiment, the topical or transdermal testosterone composition isapplied to one or more axilla of a male in need of testosteronereplacement therapy. Conditions associated with deficiency or absence ofendogenous testosterone amenable to treatment with a liquid testosteronecomposition include primary hypogonadism (congenital or acquired),including testicular failure due to conditions such as cryptorchidism,bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy,Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol orheavy metals, and hypogonadotropic hypogonadism (congenital oracquired), including idiopathic gonadotropin or luteinizinghormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamicinjury from tumors, trauma, or radiation. The topical or transdermaltestosterone composition is preferably capable of maintaining serumtestosterone concentrations in the normal range (i.e., approximately 300ng/dL to about 1050 ng/dL) following one or more applications.

Referring now to FIGS. 36-54, there is shown a modified applicator 210according to another embodiment of the present invention in which likeparts are represented by the same numerals as the first embodiment andmodified parts are identified by the same numerals but augmented by 200.As will be discussed hereafter, diaphragm holder 280 is incorporatedinto membrane 264.

As shown best in FIGS. 36-41 and 48-51, thin-walled membrane ordiaphragm 264, in embodiments made of a silicone rubber material, butnot limited thereto, has a central opening 266 of an oval shape, with athin downwardly extending wall 268 formed at the inner periphery ofcentral opening 266 which extends below central opening 266. Oval lip67, oval shaped ring 68, shallow oval recess and in-turned nubs 70 areeliminated. From the upper end of thin downwardly extending wall 268,that is, from central opening 266, membrane 264 continues upwardly alongan inner wall section 272, is folded over at its upper end to form anupper folded end 274 and then continues downwardly to form an outer wallsection 276. Lower end 278 of outer wall section 276 is thickened toform an oval shaped stiffener section 277 extending inwardly from lowerend 278. However, unlike the free end of the outer wall section of theimplement of U.S. Pat. No. 8,177,449 to Bayly et al., which is fixed tothe implement, the lower end 278 of outer wall section 276 according tothe present invention is not fixed to support 230, and in fact, is freeto move axially relative to upper section 236 during application of thefluid to the surface.

Thin downwardly extending wall 268 is fixedly secured to the outerperipheral surface of a membrane or diaphragm holder 280, andparticularly, to the outer peripheral surface of a generally oval shapedring 282 thereof by an adhesive so as to provide a sealing fittherewith. A long rib 290 extends between opposite sides of oval ring282 along the long axis thereof and a short rib 292 extends betweenopposite sides of oval ring 282 along the short axis thereof. Inaddition, other transverse ribs 293 extend in parallel, spaced apartrelation to short rib 292 between opposite sides of oval ring 282. A topwall 295 closes the upper end of oval shaped ring 282, and all ribs 290,292 and 293 are also connected to top wall 295. Central boss 94 of thefirst embodiment is eliminated. Two guide pins 296 extend down fromopposite ends of long rib 290 at the connection of ribs 290 and 293.

In addition, as shown best in FIGS. 42-47, upper section 236 of rigidsupport 230 is modified. Specifically, the upper edge of upper section236 is closed off by an upper oval shaped top wall 254, but ventopenings and central securing opening 62 are eliminated. Guide openings260 are provided to receive guide pins 296 with a tight friction andsealing fit to secure membrane 264 to upper section 236. Alternatively,and/or in addition thereto, guide pins 296 can be adhesively secured inguide openings 260. Top wall 254 has lesser dimensions than top wall 54of the first embodiment, and in this regard, an oval raised wall 255 ofa small height extends upwardly from the outer periphery of top wall 254and an oval ring wall 257 connects the outer periphery of oval raisedwall 255 and the upper edge of the side wall of upper section 236. As aresult, top wall 254 and oval raised wall 255 form an oval recessed area259 which receives thin downwardly extending wall 268 of membrane 264and oval shaped ring 282 of diaphragm holder 280.

In order to better provide for controlled free sliding movement of lowerend 278 of outer wall section 276, in a preferred embodiment best shownin FIGS. 52-54, lower end 278 is fixed over a skirt 302 formed by anoval shape ring wall 305 having an outwardly extending lower ledge orplate 306 at the lower edge thereof, and an oval recessed area 310 inthe outer surface of ring wall 305, extending from a position from lowerledge 306 to a position about halfway up ring wall 305. The lower end ofouter wall section 276 is stretch fit over skirt 302, with oval shapedstiffener section 277 fit within oval recessed area 310. The innerdimensions of ring wall 305 are larger than the outer dimensions ofupper section 236 so that it can slide up and down relative to uppersection 236.

The operation of the modified applicator 210 is the same as the firstapplicator 10 described above.

It will be appreciated that modifications to the present invention canbe made to the scope of the present invention as defined by the appendedclaims. Thus, for example, while many parts have been described ashaving an oval shape, the present invention is not limited thereby, andany other suitable shape can be used. In particular, generally circular,square, and rectangular shapes are useful.

Having described certain specific aspects and embodiments of theinvention with reference to the accompanying drawings, it will beappreciated that the present invention is not limited to those preciseembodiments and that various changes and modifications can be effectedtherein by one of ordinary skill in the art without departing from thescope or spirit of the invention as defined by the appended claims.

What is claimed is:
 1. An applicator for applying a fluid to a surface,the applicator comprising: 1) a thin-walled, rigid support comprisingthree thin-walled sections, a lower section, an intermediate section,and an upper section connected to each other in succession; 2) aflexible membrane comprising a central opening, an inner wall comprisinga lower end and an upper end, an outer wall at least partiallysurrounding the upper outer surface of the support, the outer wallcomprising a lower end and an upper end, and an upper folded wallconnecting the upper ends of the inner wall and outer wall; and 3) amembrane holder for fixedly securing the lower end of the inner wall ofthe flexible membrane to the upper section of the support; wherein anupper surface of the membrane holder and the inner wall of the flexiblemembrane define a reservoir for holding a fluid.
 2. The applicator ofclaim 1, wherein the lower end of the outer wall of the flexiblemembrane is free to move axially relative to the upper section of thesupport when pressure is applied to the upper folded wall of theflexible membrane.
 3. The applicator of claim 1, wherein the support isopen at a lower end thereof adapted to removably mount on a dispenserbottle containing a fluid.
 4. The applicator of claim 1, wherein thesupport is adapted to engage a cap to cover the flexible membrane. 5.The applicator of claim 1, wherein the membrane holder covers and closesthe central opening of the flexible membrane.
 6. The applicator of claim1, wherein the upper folded wall of the flexible membrane deformsrelatively uniformly around its perimeter along an axis that istransverse to the central opening when pressure is applied to the upperfolded wall.
 7. The applicator according to claim 6, wherein a vacuumseal is formed when pressure is applied to the upper folded wall againsta solid or semi-solid surface.
 8. The applicator of claim 1, furthercomprising a skirt secured to the lower end of the outer wall of theflexible membrane, the skirt having dimensions larger than outerdimensions of the upper section of the support for freely moving axiallyrelative to the upper section of the support when pressure is applied tothe upper folded wall of the flexible membrane.
 9. A method of treatinga deficiency of endogenous testosterone in a patient in need thereof,the method comprising providing the applicator of claim 1, placing atestosterone composition in the applicator, and applying thetestosterone composition from the applicator to skin of the patient, 10.The method of claim 9, wherein the deficiency of testosterone is theresult of a condition selected from the group consisting of primaryhypogonadism and hypogonadotropic hypogonadism.
 11. The method of claim10, wherein the primary hypogonadism is testicular failure from acondition selected from the group consisting of cryptorchidism,bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy,Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol orheavy metals.
 12. The method of claim 10, wherein the hypogonadotropichypogonadism is selected from the group consisting of idopathicgonadotropin deficiency, luteinizing hormone-releasing hormone (LHRH)deficiency, or pituitary-hypothalmic injury from tumors, trauma, orradiation.
 13. The method of claim 9, wherein the patient is a male. 14.The method of claim 9, wherein the testosterone composition is a topicalor transdermal testosterone composition.
 15. The method of claim 14,wherein the topical or transdermal testosterone composition maintains aserum testosterone concentration in the patient in the range of about300 ng/dL to about 1050 ng/dL.
 16. The method of claim 9, wherein thetestosterone composition is applied to one or more axilla of thepatient.
 17. A kit comprising: the applicator of claim 1; a dispensorbottle containing a testosterone composition; and a cap adapted toengage the support and cover the flexible membrane of the applicator.18. The kit of claim 17, wherein the testosterone composition is atopical or transdermal testosterone composition.
 19. The kit of claim17, wherein the applicator further comprises a skirt secured to thelower end of the outer wall of the flexible membrane, the skirt havingdimensions larger than outer dimensions of the upper section of thesupport for freely moving axially relative to the upper section of thesupport when pressure is applied to the upper folded wall of theflexible membrane.